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NCT00683046 · REGISTRY CONDITION SEARCH

T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-11-22

Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Disease-free Survival

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outcome · POSTED

Median Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Zubrod performance status 2 (See Appendix B). * Life expectancy is not severely limited by concomitant illness. * Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * Serum creatinine \<1.5 mg/dL or Creatinine Clearance \>50 ml/min . * Serum bilirubin 2.0 mg/dl, SGPT \<3 x upper limit of normal * No evidence of chronic active hepatitis or cirrhosis. * HIV-negative * Patient is not pregnant * Patient or guardian able to sign informed consent. Exclusion Criteria: * N/A
healthy Volunteers
false
maximum Age
100 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Fludarabine
    2. Drug: Melphalan
    3. Drug: Stem cells
    4. Drug: Campath
    label
    Drug Intervention
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Drug Intervention
    description
    Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.
    name
    Fludarabine
    type
    DRUG
  2. arm Group Labels
    1. Drug Intervention
    description
    Melphalan 140 mg/m2 IV on day -2.
    name
    Melphalan
    type
    DRUG
  3. arm Group Labels
    1. Drug Intervention
    description
    Stem cell infusion on day 0.
    name
    Stem cells
    type
    DRUG
  4. arm Group Labels
    1. Drug Intervention
    description
    Campath, 20 mg IV on day -7, 6, -5, -4, and -3.
    name
    Campath
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
204
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
    measure
    Median Disease-free Survival
    time Frame
    Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
secondary Outcomes
  1. description
    All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
    measure
    Median Overall Survival
    time Frame
    Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
Full study description
brief Summary
Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-44f2df8bd345ac22e5fe
      requested nct id
      NCT00683046
      primary nct id
      NCT00683046
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      d0aa7815257fae410d821b25d39a3052c5743f6249352f56325edfaeb907134a
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-44f2df8bd345ac22e5fe
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00683046
      occurrences
      1. context exact
        NCT00683046
        end
        11
        exact text
        NCT00683046
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/325/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      3795cbad5e09de159cdbee0d31482013c12d5753825fa0d3761b50750134d27f

    Preserved source evidence · Not medical advice